Scientific and Clinical Careers

Job Title

Scientific & Clinical Job Details

QC Analyst

Job Code: #505
Job Type: Direct Hire
Salary: $40,000 - $45,000
Job Location: Hoffman Estates, IL
Posted 2 weeks ago

Job Description

Job Title: QC Analyst 

Salary: 45k-50k some flexibility based on experience

Position Summary: This is a role very similar to QA.  This is not a lab position as this individual will be reviewing 100% of the data generated from our small and large molecule studiesConduct lab activities in accordance with applicable methods, Plans, SOPs/SWPs, and GLP regulatory guidelines (21 CFR Part 11) under guidance from Senior Analysts and Principle Investigator. Review datasets, work sheet and reports to identify and assess inaccuracies in accordance with applicable methods, protocols, SOPs and regulatory guidelines under the guidance of the Principal Investigator in support of the sponsor’s studies.  Ability to make recommendations for QC process improvement, ensure data integrity and provide training for junior QCer.  Effectively communicate QC review findings with lab staff and management.  Maintain study documentation and lab records.  Participate with the team to meet group goals. 

Job Requirements:

  • B.S. in related field, M.S. preferred, or Equivalent with 1+ years industry (pharmaceutical or bio lab) experience.
  • 3+ years working in a GLP environment.
  • Understand GLP requirements, SOP/S
  • WPs and related lab procedures; safety policies and company policies.
  • Review datasets, work sheet and reports to identify and assess inaccuracies in accordance with applicable methods, protocols, SOPs and regulatory guidelines under the guidance of the Principal Investigator in support of the sponsor’s studies.
  • Report review findings and communicate with PI and other lab staff.
  • Maintain accurate records of work and study documentation per Good Documentation Practices as per SOPs.
  • Be organized and pay close attention to detail to optimize quality processes.
  • Implement scientific theory with proper skills (i.e. LC-MS/MS, HPLC)
  • Maintain quality execution and work.